Oral beclomethasone dipropionate as an alternative to systemic steroids in mild to moderate ulcerative colitis not responding to aminosalicylates.

Background: Aminosalicylates (5-ASA) are first-line treatment for mild-moderate ulcerative colitis (UC). Systemic corticosteroids (CS) are considered for patients in whom 5-ASA has been unsuccessful, but their use is limited by adverse effects. Beclomethasone dipropionate (BDP), a topically acting steroid with low systemic bioavailability, has a more favorable safety profile, but its role in clinical practice is not yet well established.

Aim: The aim of the present study is to assess whether oral BDP can be an alternative treatment to systemic CS for patients with mild-moderate UC not responding to first-line therapy with 5-ASA.

Methods: From 2003 to 2006, all consecutive patients with mild-moderate UC unresponsive to oral and topical 5-ASA (+/-topical CS) administered for at least 3 weeks received an 8-week course of oral BDP (10 mg/day for 4 weeks and 5 mg/day for an additional 4 weeks). Co-primary end-points were: (1) clinical remission within 8 weeks, without need of systemic CS; (2) steroid-free remission for 12 months.

Results: Sixty-four patients were included. In this study, within 8 weeks, 48/64 patients (75%) entered remission without systemic CS, while 16/64 (25%) failed to enter remission. Within 12 months, 37/64 patients (58%) had prolonged steroid-free remission, while 11/64 (17%) relapsed. During 1 year, 75% of patients receiving oral BDP could avoid systemic CS.

Conclusions: Oral BDP can avoid the use of systemic CS in the vast majority of patients with mild-moderate UC not responding to 5-ASA and could be considered as a second-line treatment for these patients.